Medical Device Registration and Approval in Indonesia
General country-specific regulatory information is provided on this page for medical device registration and approval in Indonesia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Indonesia, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Indonesia
REGULATORY AUTHORITY: Ministry of Health (MoH)
CLASSIFICATION SYSTEM: Medical Devices/IVDs: Class A/B/C/D or 1/2/3
TIMEFRAME:
Medical Devices/IVDs – Official Timeline:
Class A – 45 working days
Class B/C – 60 working days
Class D – 80 working days
Medical Devices/IVDs – Actual Timeline (based on experience):
Class A – 1 to 2 months
Class B/C – 3 to 4 months
Class D – 4 to 6 months
SPECIAL REQUIREMENTS:
On-site Audit: Not required.
Local Tests/Permit: May be required for some devices such as disposable sterile syringes, HIV test products, medical devices that contain/transmit radiation, medical devices that transmit radiofrequency/Bluetooth.
Local Clinical Evaluation or Studies: Not required.
LOCAL FEES (New Application):
Medical Devices & In-vitro Diagnostics (IVDs)
Class A: USD $100
Class B/C: USD $200
Class D: USD $333
LOCAL FEELS (Manufacturer): No manufacturer registration is required. The local authorized representative, however, must be an establishment that holds a valid Medical Device Distributor License (MDDL) and implements a Good Distribution Practice of Medical Device (GDPMD).
LICENSE VALIDITY: Maximum 5 years (depending on the validity of authorization letter issued by the foreign manufacturer).
LICENSE TRANSFER: License transfer is possible but new registration is required.
AUTHORIZED REPRESENTATIVE: A solely local authorized representative should be appointed by an overseas manufacturer through official Letter of Authorization (LoA).
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